Bacterial Reduction After Supplementary Disinfection Procedures in Infected Root Canals

Conditions

• Dental Pulp Necroses

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• GentleWave System Root Canal Therapy — DEVICE
  This device has 510k market approval for its intended use within this study.
• EdgePro Laser Root Canal Therapy — DEVICE
  This device has 510k market approval for its intended use within this study.
• The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy — DEVICE
  This device has 510k market approval for its intended use within this study.

Study Details

The purpose of this study is to understand the effect that 3 different types of root canal procedures have on bacteria.

Key Dates

Start date

Aug 20, 2024

Status verified

Aug 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

90 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: GentleWave System Root Canal Therapy
  Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the GentleWave System root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.
• Experimental: EdgePro Laser Root Canal Therapy
  Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the EdgePro Laser root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.
• Experimental: The ProUltra Piezo Ultrasonic with EndoUltra Tips Root Canal Therapy
  Sterile paper points will be inserted into the root canal at 3 time points: (i) before instrumentation, (ii) after washing the canal with 10% sodium thiosulfate, and (iii) after the ProUltra Piezo Ultrasonic with EndoUltra Tips root canal therapy has been completed. The paper points will collect bacteria, which will be analyzed via real-time Polymerase Chain Reaction to assess bacterial counts.

Primary Outcome Measure

Assessment of the changes in the bacterial count at various time points during the root canal procedure. [ Time Frame: Baseline (pre-intervention) and during the intervention and immediately after the intervention ]

Central Contacts

• Abhishek Parolia, PhD, MDS
  (319) 335-7471
  [email protected]

Locations (1)

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